Quality in care homes: How wearable devices and social network analysis might help

Social network analysis can support quality improvement in care homes but traditional approaches to social network analysis are not always feasible in care homes. Recalling contacts and movements in a home is difficult for residents and staff and documentary and other sources of individual contacts can be unreliable. Bluetooth enabled wearable devices are a potential means of generating reliable, trustworthy, social network data in care home communities. In this paper, we explore the empirical, theoretical and real-world potential and difficulties in using Bluetooth enabled wearables with residents and staff in care homes for quality improvement. We demonstrate, for the first time, that a relatively simple system built around the Internet of Things, Bluetooth enabled wearables for residents and staff and passive location devices (the CONTACT intervention) can capture social networks and data in homes, enabling social network analysis, measures, statistics and visualisations. Unexpected variations in social network measures and patterns are surfaced, alongside “uncomfortable” information concerning staff time spent with residents. We show how technology might also help identify those most in need of social contact in a home. The possibilities of technology-enabled social network analysis must be balanced against the implementation-related challenges associated with introducing innovations in complex social systems such as care homes. Behavioural challenges notwithstanding, we argue that armed with social network information, care home staff could better tailor, plan and evaluate the effects of quality improvement with the sub-communities that make up a care home community

‘Smart’ BLE wearables for digital contact tracing in care homes during the COVID-19 pandemic—a process evaluation of the CONTACT feasibility study

Background: Rapid and mass transmission of the SARS-CoV-2 virus amongst vulnerable people led to devastating effects from COVID-19 in care homes. The CONTACT intervention introduced Bluetooth Low Energy ‘smart’ wearable devices (BLE wearables) as a basis for automated contact tracing in, and feedback on infection risks and patterns to, care homes to try and improve infection prevention and control (IPC). We planned a cluster randomised controlled trial (RCT) of CONTACT. To be feasible, homes had to adopt CONTACT’s technology and new ways of working. This paper reports on the process evaluation conducted alongside CONTACT’s feasibility study and explains why it lacked the feasibility and acceptability for a definitive RCT. Methods: This mixed method process evaluation used Normalisation Process Theory (NPT) qualitative (interviews, field notes, study case report forms and documents, and observation) and quantitative (survey instruments, counts of activity) data to plan, implement, and analyse the mechanisms, effects, and contextual factors that shaped the feasibility and acceptability of the CONTACT intervention. Results: Thirteen themes within four core NPT constructs explained CONTACT’s lack of feasibility. Coherence: the home’s varied in the scale and extent of commitment and understanding of the technology and study procedures. Leadership credibility was important but compromised by competing priorities. Management and direct care staff saw CONTACT differently. Work to promote (cognitive participation) and enact (collective action) CONTACT was burdensome and failed to be prioritised over competing COVID-19-related demands on time and scarce human and cognitive resources. Ultimately, staff appraisal of the value of CONTACT-generated information and study procedures (reflexivity) was that any utility for IPC was insufficient to outweigh the perceived burden and complexity involved. Conclusions: Despite implementation failure, dismissing BLE wearables’ potential for contact tracing is premature. In non-pandemic conditions, with more time, better co-design and integration of theory-driven implementation strategies tailored to care homes’ unique contexts, researchers could enhance normalisation in readiness for future pandemic challenges. Trial registration: ISRCTN registration: 11,204,126 registered 17/02/2021

Why the trial researcher matters: Day-to-day work viewed through the lens of normalization process theory

Researchers working in the field, the places where research-relevant activity happens, are essential to recruitment and data collection in randomised controlled trials (RCTs). This study aimed to understand the nature of this often invisible work. Data were generated through an RCT of a pharmacist-led medication management service for older people in care homes. The study was conducted over three years and employed seven Research Associates (RA) working in Scotland, Northern Ireland, and England. Weekly research team meetings and Programme Management Group meetings naturally generated 129 sets of minutes. This documentary data was supplemented with two end-of-study RA debriefing meetings. Data were coded to sort the work being done in the field, then deductively explored through the lens of Normalization Process Theory to enable a greater understanding of the depth, breadth and complexity of work carried out by these trial delivery RAs. Results indicate RAs helped stakeholders and participants make sense of the research, they built relationships with participants to support retention, operationalised complex data collection procedures and reflected on their own work contexts to reach agreement on changes to trial procedures. The debrief discussions enabled RAs to explore and reflect on experiences from the field which had affected their day-to-day work. The learning from the challenges faced in facilitating care home research may be useful to inform future research team preparation for complex interventions. Scrutinising these data sources through the lens of NPT enabled us to identify RAs as linchpins in the successful conduct of a complex RCT study

Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes: cluster randomised controlled trial

Objective: To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes. Design: Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes. Setting: Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads. Participants: 49 triads and 882 residents were randomised. Participants were care home residents, aged ≥65 years, taking at least one prescribed drug, recruited to 20 residents/triad. Intervention: Each pharmacy independent prescriber provided pharmaceutical care to approximately 20 residents across one to three care homes, with weekly visits over six months. Pharmacy independent prescribers developed a pharmaceutical care plan for each resident, did medicines reviews/reconciliation, trained staff, and supported with medicines related procedures, deprescribing, and authorisation of prescriptions. Participants in the control group received usual care. Main outcomes measures: The primary outcome was fall rate/person at six months analysed by intention to treat, adjusted for prognostic variables. Secondary outcomes included quality of life (EQ-5D by proxy), Barthel score, Drug Burden Index, hospital admissions, and mortality. Assuming a 21% reduction in falls, 880 residents were needed, allowing for 20% attrition. Results: The average age of participants at study entry was 85 years; 70% were female. 697 falls (1.55 per resident) were recorded in the intervention group and 538 falls (1.26 per resident) in the control group at six months. The fall rate risk ratio for the intervention group compared with the control group was not significant (0.91, 95% confidence interval 0.66 to 1.26) after adjustment for all model covariates. Secondary outcomes were not significantly different between groups, with exception of the Drug Burden Index, which significantly favoured the intervention. A third (185/566; 32.7%) of pharmacy independent prescriber interventions involved medicines associated with falls. No adverse events or safety concerns were identified. Conclusions: Change in the primary outcome of falls was not significant. Limiting follow-up to six months combined with a small proportion of interventions predicted to affect falls may explain this. A significant reduction in the Drug Burden Index was realised and would be predicted to yield future clinical benefits for patients. This large trial of an intensive weekly pharmacist intervention with care home residents was also found to be safe and well received

The Care Home Independent Pharmacist Prescriber Study (CHIPPS): development and implementation of an RCT to estimate safety, effectiveness and cost-effectiveness

Background Medicine prescribing, monitoring and administration in care homes can be significantly enhanced. Effective interventions to improve pharmaceutical care and resident outcomes are required. The enablement of pharmacists to prescribe provides an opportunity for pharmacist independent prescribers to assume responsibility for improving pharmaceutical care, medication-related outcomes and resident safety whilst reducing general practitioner workload. Objective(s) To determine the effectiveness and cost-effectiveness of pharmacist independent prescribing in care homes. Design Development work was undertaken through five work packages before the delivery of the definitive trial. Triads of pharmacist independent prescribers, care home and general practice with responsibility over 20 care home residents were recruited and cluster randomised to intervention or usual care for 6 months. Researchers were blinded at recruitment stage only. Recruitment of 880 residents was required to provide 80% statistical power, to show a 21% reduction in falls over 6 months, assuming 20% attrition. Randomisation was undertaken electronically at triad level, stratified by geographical area. Intention-to-treat analysis undertaken using a negative binomial model. Parameters were estimated using a generalised estimating equation approach. Costs were captured from an NHS perspective. Quality of life (EuroQol; five domain; five level) was collected by proxy to enable cost/quality-adjusted life-year estimation. A concurrent process evaluation was performed. Safety was monitored through a review of pharmacist independent prescriber activities, independent concerns reporting and review of adverse events. Participants Forty-nine triads of general practitioners, pharmacist independent prescribers and care homes were recruited with 454 residents allocated to the intervention arm and 428 to the control arm. Intervention Medication review and care planning, medication reconciliation, staff training, support with care home medication-related procedures, deprescribing and authorisation of monthly prescriptions. Main outcome measure Fall rate per person over 6 months. Results Data for 449 intervention and 427 control residents available for final analysis. The 6-month fall rate ratio in favour of intervention was 0.91 (95% confidence interval 0.66 to 1.26; p=0.58). No significant difference in secondary outcomes was identified except Drug Burden Index (rate ratio 0.83, 95% confidence interval 0.75 to 0.92; p<0.001). No harms were identified. One quarter of medication-related interventions were associated with a reduced risk of falls. The intervention was positively received. Limitations Participant self-selection bias may have affected the generalisability of findings. Open-label cluster randomised controlled trial limited by 6-month follow-up. Potential ceiling effect due to concurrent pharmacist-led interventions. Falls potentially insufficiently proximal to the intervention. Conclusions To enhance effectiveness and acceptance of the proposed model, effective integration into care home and general practitioner teams was identified as a central requirement. A core outcome set and a training package were developed. The final model of care, whilst being safe and well received and resulting in a reduction in drug burden, demonstrated no improvement in the primary outcome of falls. With no improvement in quality-adjusted life-years identified, the pharmacist independent prescriber intervention was not estimated to be cost-effective. Future work To develop and evaluate better models of care for enhancing medication outcomes and safety in care homes or re-test with a longer intervention and follow-up period and a stronger primary outcome. Trial registration This trial is registered as ISRCTN10663852, definitive trial: ISRCTN17847169. Study registration This study is registered as PROSPERO CRD20150907. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0613-20007) and is published in full in Programme Grants for Applied Research; Vol. 11, No. 10. See the NIHR Funding and Awards website for further award information

Development of a Core Outcome Set for effectiveness trials aimed at optimising prescribing in older adults in care homes

Background: Prescribing medicines for older adults in care homes is known to be sub-optimal. Whilst trials testing interventions to optimise prescribing in this setting have been published, heterogeneity in outcome reporting has hindered comparison of interventions, thus limiting evidence synthesis. The aim of this study was to develop a core outcome set (COS), a list of outcomes which should be measured and reported, as a minimum, for all effectiveness trials involving optimising prescribing in care homes. The COS was developed as part of the Care Homes Independent Pharmacist Prescribing Study (CHIPPS). Methods: A long-list of outcomes was identified through a review of published literature and stakeholder input. Outcomes were reviewed and refined prior to entering a two-round online Delphi exercise and then distributed via a web link to the CHIPPS Management Team, a multidisciplinary team including pharmacists, doctors and Patient Public Involvement representatives (amongst others), who comprised the Delphi panel. The Delphi panellists (n = 19) rated the importance of outcomes on a 9-point Likert scale from 1 (not important) to 9 (critically important). Consensus for an outcome being included in the COS was defined as ≥70% participants scoring 7–9 and <15% scoring 1–3. Exclusion was defined as ≥70% scoring 1–3 and <15% 7–9. Individual and group scores were fed back to participants alongside the second questionnaire round, which included outcomes for which no consensus had been achieved. Results: A long-list of 63 potential outcomes was identified. Refinement of this long-list of outcomes resulted in 29 outcomes, which were included in the Delphi questionnaire (round 1). Following both rounds of the Delphi exercise, 13 outcomes (organised into seven overarching domains: medication appropriateness, adverse drug events, prescribing errors, falls, quality of life, all-cause mortality and admissions to hospital (and associated costs)) met the criteria for inclusion in the final COS. Conclusions: We have developed a COS for effectiveness trials aimed at optimising prescribing in older adults in care homes using robust methodology. Widespread adoption of this COS will facilitate evidence synthesis between trials. Future work should focus on evaluating appropriate tools for these key outcomes to further reduce heterogeneity in outcome measurement in this context

Process evaluation for the Care Homes Independent Pharmacist Prescriber Study (CHIPPS)

BACKGROUND: Medicines management in care homes requires significant improvement. CHIPPS was a cluster randomised controlled trial to determine the effectiveness of integrating pharmacist independent prescribers into care homes to assume central responsibility for medicines management. This paper reports the parallel mixed-methods process evaluation. METHOD: Intervention arm consisted of 25 triads: Care homes (staff and up to 24 residents), General Practitioner (GP) and Pharmacist Independent Prescriber (PIP). Data sources were pharmaceutical care plans (PCPs), pharmacist activity logs, online questionnaires and semi-structured interviews. Quantitative data were analysed descriptively. Qualitative data were analysed thematically. Results were mapped to the process evaluation objectives following the Medical Research Council framework. RESULTS: PCPs and activity logs were available from 22 PIPs. Questionnaires were returned by 16 PIPs, eight GPs, and two care home managers. Interviews were completed with 14 PIPs, eight GPs, nine care home managers, six care home staff, and one resident. All stakeholders reported some benefits from PIPs having responsibility for medicine management and identified no safety concerns. PIPs reported an increase in their knowledge and identified the value of having time to engage with care home staff and residents during reviews. The research paperwork was identified as least useful by many PIPs. PIPs conducted medication reviews on residents, recording 566 clinical interventions, many involving deprescribing; 93.8% of changes were sustained at 6 months. For 284 (50.2%) residents a medicine was stopped, and for a quarter of residents, changes involved a medicine linked to increased falls risk. Qualitative data indicated participants noted increased medication safety and improved resident quality of life. Contextual barriers to implementation were apparent in the few triads where PIP was not known previously to the GP and care home before the trial. In three triads, PIPs did not deliver the intervention. CONCLUSIONS: The intervention was generally implemented as intended, and well-received by most stakeholders. Whilst there was widespread deprescribing, contextual factors effected opportunity for PIP engagement in care homes. Implementation was most effective when communication pathways between PIP and GP had been previously well-established. TRIAL REGISTRATION: The definitive RCT was registered with the ISRCTN registry (registration number ISRCTN 17847169). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12913-021-07062-3

The Care Home Independent Pharmacist Prescriber Study (CHIPPS): development and implementation of an RCT to estimate safety, effectiveness and cost-effectiveness

Background Medicine prescribing, monitoring and administration in care homes can be significantly enhanced. Effective interventions to improve pharmaceutical care and resident outcomes are required. The enablement of pharmacists to prescribe provides an opportunity for pharmacist independent prescribers to assume responsibility for improving pharmaceutical care, medication-related outcomes and resident safety whilst reducing general practitioner workload. Objective(s) To determine the effectiveness and cost-effectiveness of pharmacist independent prescribing in care homes. Design Development work was undertaken through five work packages before the delivery of the definitive trial. Triads of pharmacist independent prescribers, care home and general practice with responsibility over 20 care home residents were recruited and cluster randomised to intervention or usual care for 6 months. Researchers were blinded at recruitment stage only. Recruitment of 880 residents was required to provide 80% statistical power, to show a 21% reduction in falls over 6 months, assuming 20% attrition. Randomisation was undertaken electronically at triad level, stratified by geographical area. Intention-to-treat analysis undertaken using a negative binomial model. Parameters were estimated using a generalised estimating equation approach. Costs were captured from an NHS perspective. Quality of life (EuroQol; five domain; five level) was collected by proxy to enable cost/quality-adjusted life-year estimation. A concurrent process evaluation was performed. Safety was monitored through a review of pharmacist independent prescriber activities, independent concerns reporting and review of adverse events. Participants Forty-nine triads of general practitioners, pharmacist independent prescribers and care homes were recruited with 454 residents allocated to the intervention arm and 428 to the control arm. Intervention Medication review and care planning, medication reconciliation, staff training, support with care home medication-related procedures, deprescribing and authorisation of monthly prescriptions. Main outcome measure Fall rate per person over 6 months. Results Data for 449 intervention and 427 control residents available for final analysis. The 6-month fall rate ratio in favour of intervention was 0.91 (95% confidence interval 0.66 to 1.26; p=0.58). No significant difference in secondary outcomes was identified except Drug Burden Index (rate ratio 0.83, 95% confidence interval 0.75 to 0.92; p<0.001). No harms were identified. One quarter of medication-related interventions were associated with a reduced risk of falls. The intervention was positively received. Limitations Participant self-selection bias may have affected the generalisability of findings. Open-label cluster randomised controlled trial limited by 6-month follow-up. Potential ceiling effect due to concurrent pharmacist-led interventions. Falls potentially insufficiently proximal to the intervention. Conclusions To enhance effectiveness and acceptance of the proposed model, effective integration into care home and general practitioner teams was identified as a central requirement. A core outcome set and a training package were developed. The final model of care, whilst being safe and well received and resulting in a reduction in drug burden, demonstrated no improvement in the primary outcome of falls. With no improvement in quality-adjusted life-years identified, the pharmacist independent prescriber intervention was not estimated to be cost-effective. Future work To develop and evaluate better models of care for enhancing medication outcomes and safety in care homes or re-test with a longer intervention and follow-up period and a stronger primary outcome. Trial registration This trial is registered as ISRCTN10663852, definitive trial: ISRCTN17847169. Study registration This study is registered as PROSPERO CRD20150907. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0613-20007) and is published in full in Programme Grants for Applied Research; Vol. 11, No. 10. See the NIHR Funding and Awards website for further award information